NEUTROGENA HYDRO BOOST WATER GEL SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, and octocrylene lotion

Neutrogena Hydro Boost Water Gel Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Neutrogena Hydro Boost Water Gel Sunscreen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Avobenzone 3%	Sunscreen
Homosalate 15%	Sunscreen
Octisalate 5%	Sunscreen
Octocrylene 10%	Sunscreen

Uses

• Helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

• Do not use on damaged or broken skin

• When using this product keep out of eyes. Rinse with water to remove.

• Stop use and ask a doctor if rash occurs

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor

Other information

• protect this product from excessive heat and direct sun
• protect from freezing
• May stain some fabrics

Inactive ingredients

Water, Butyloctyl Salicylate, Glycerin, Alcohol Denat., Silica, Caprylyl Methicone, Aluminum Starch Octenylsuccinate, Dimethicone, Polyurethane-62, Phenoxyethanol, Pentylene Glycol, Styrene/Acrylates Copolymer, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Acrylates/Dimethicone Copolymer, Fragrance, Glyceryl Stearate, Chlorphenesin, Menthyl Lactate, Tocopheryl Acetate, Disodium EDTA, Trideceth-6, Hydrolyzed Hyaluronic Acid, Sodium Hydroxide, Blue 1

Questions or comments?

Call toll-free 800-299-4786 or 215-273-8755 (collect) www.neutrogena.com

SPL UNCLASSIFIED SECTION

Distributed by: JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

Hydro

Boost

water gel lotion

sunscreen

BROAD SPECTRUM SPF 50

50

helioplex ®

broad spectrum uva.uvb

invisible finish

oxybenzone free

water resistant (80 minutes)

3.0 FL OZ (88 mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA HYDRO BOOST WATER GEL SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0669
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CHLORPHENESIN (UNII: I670DAL4SZ)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0669-3	88 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2020

Labeler - Johnson & Johnson Consumer Inc. (118772437)